Trocar and sheath assembly for placement of implantable device adjacent a body lumen

ABSTRACT

The present subject matter provides a trocar and sheath assembly for placement of implantable devices adjacent a body lumen, and a method of using the trocar and sheath assembly for implanting an implantable device at a target site for controllable coaptation of a patient&#39;s urethra.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. application Ser. No.14/517,143, filed Oct. 17, 2014, which application claims the benefit ofthe filing date of U.S. application Ser. No. 61/892,960, filed on Oct.18, 2013, the disclosure of which are incorporated by reference herein.

FIELD OF THE INVENTION

The present subject matter relates to methods and apparatus to assist inintroducing implantable devices for treating urinary incontinence.

BACKGROUND

Incontinence is a complex disorder with often more than one cause, afactor that has complicated the search for effective solutions. The fivemajor categories of incontinence include: overflow, urge, stress, mixed(combination of both urge and stress), and functional. Male incontinencemakes up approximately 15% (1.4 million) of the urinary incontinencepopulation (male and female) with the majority experiencing mixedincontinence, followed by urge or stress incontinence. Stress urinaryincontinence is a well-known complication of radical prostatectomy andtransurethral resection of the prostate (TURP).

Several large studies have examined the median probability fordeveloping stress urinary incontinence following all forms of surgeryfor benign prostatic hyperplasia (BPH). The European Association ofUrology (EAU) and the American Urological Association (AUA), as well asthe National Health and Medical Research Council (NHMRC) of Australiahave all conducted extensive literature searches and reviews, examiningthe outcomes of surgeries for BPH. Incontinence rates reported by thesethree reviews following transurethral incision of the prostate (TUIP)range between 0.1%-0.75%, and following TURP between 1%-2.2%. Openprostatectomy produces between 0.5%-1.9% incontinent patients. The NHMRCsummary reported total incontinence and stress incontinence separately,with the incidence of 1% (90% CI 0.7-14%) and 2.1% (90% CI 1.75-2.5%)respectively found in the literature. Of the three operations, TURP isthe most widely and commonly employed procedure. Approximately 195,000TURPs are performed annually in the USA.

Benoit et al. (Urol., 56:116 (2000)) examined the records of 25,651 menwho were reported under Medicare statistics in 1991 as having undergonea radical retropubic prostatectomy (RRP) for cancer of the prostate.Nearly 22% (5573 of 25,651 men) reported incontinence post RRP and at 12months post-RRP, 8% (2025 men) continued to carry this diagnosis.

The largest study to date to assess the frequency of diagnosis ofprostate carcinoma and post prostatectomy incontinence is Mifflin et al.(Cancer, 83:1679 (1995)). Data from 1,114 hospitals and 103,979 subjectsdiagnosed with prostate cancer in 1992 were surveyed. The survey teamdefined regular urinary incontinence as an unwanted loss of urine atleast twice over the past month. The results demonstrated the overallrate of incontinence to be up to 20-22% in the community dwellingpatients and that the surgical mortality rates from the surgery wereapproximately one percent.

The majority of men with incontinence associated with various forms ofprostatectomy are conservatively managed using absorbent products(pads/adult diapers) or occlusive products (penile clamps) while thepatient “watches and waits” to see whether improvement will occur withthe passage of time. Most reports on post-prostatectomy incontinence andits treatment agree that a follow-up period of at least 12 months isnecessary before confirming an individual's status as one of establishedincontinence.

Stress urinary incontinence has a high probability of natural resolutionwithin the first year post-surgery (Mebust, Chapter 49 in Campbell'sUrology, p. 1511 (1998)). During this period several therapies, such aspelvic floor training, medication, and bulking agents, may be helpful inrestoring continence sooner, but differences compared with no treatmenttypically disappear by 12 months post-procedure. Stress incontinencelasting longer than 12 months, and/or not responding to conservativetreatment may be improved using surgically implanted devices. Devicesinclude the Artificial Urethral Sphincter (AUS) and sub-urethral slings.

The AUS is currently considered the gold standard for treatment forchronic stress urinary incontinence especially severe cases. Theimplantation of device qualifies as a major procedure with requiredsurgical placement of several components including the circumferentialurethral cuff, the pressure-regulating balloon, and the scrotal pumpwhich controls inflation and deflation of the urethral cuff forcontinence. This cuff mechanism eliminates passage of urine; therecipient manipulates the device to open the urethra. Manipulationrequires some manual dexterity. Revisions of the AUS typically involvesurgical risks consistent with the original procedure. With AUS, thereoperation rate is found to be 22-25% but the reoperation rate is bothcomplicated and invasive.

Sub-urethral slings represent a variety of devices based on passive,semi-circumferential urethral compression. Devices differ in materialand in how and/or where they are anchored. Most are fixed, like the AUS,but a few feature adjustable tension, e.g. Remeex System (K062341).Published literature reviews (Mebust, supra, and Borgermann et al.,107:454 (2010)) suggest improvement rates (less stringent than socialcontinence) of 75% to 90% with easier implantation and fewer adverseevents and revisions than the AUS in mild to moderate cases. The mostcommon adverse events reported were infection, 0% to 6%, urethralerosion, 0% to 2% and post implant scrotum pain or numbness resolvingwithin three months, 16% to 72%. Urethral slings are cheaper and lessinvasive and show dry rates of 42-70% (Rocha et al., Urol., 71:85(2005)). Slings however, carry a considerable risk of urinary retentionand pain (Herschorn et al., Neural. Urodvn. 29:179 (2010)). Lessinvasive treatments, such as the injection of a bulking agent(Macrroplastique) in the external sphincter, have also been tried butthe long-term results are poor: only 25% of the patients have anytreatment effect on pad use after 12 months (Stein et al., J. Urol.,173:1654 (2005)).

SUMMARY

The present subject matter provides methods and apparatus to assist inthe placement of implantable devices adjacent a body lumen. For example,an incision is made and a needle is inserted through solid tissue untilthe needle tip is near the target site, then the needle is withdrawn. Inone embodiment, an incision is made near the perineum, for instance, twosmall incisions of approximately 1.0 cm one on each side of the perinealmidline, and a needle is inserted through tissue until the needle tip isnear the target site, e.g., anastomosis, then, in one embodiment, theneedle is withdrawn. In one embodiment, a guidewire, e.g., a flexibleguidewire such as one with a coil around a single straight wire or awire with a J-tip, or a stylet, e.g., a stiff solid wire, is insertedthrough or adjacent to the needle. In one embodiment, a trocar, e.g., amated trocar, enveloped in a U-channel sheath (a trocar/sheath assembly)is then inserted, with ultrasound guidance if necessary. In oneembodiment, the assembly is inserted into tissue over the guidewire orstylet, e.g., the trocar has a lumen which is employed to advance theassembly over the guidewire or stylet, and then the trocar, andoptionally the guidewire or stylet, is/are withdrawn. A sheath can beused to introduce other devices, e.g., implantable devices, to thetarget site. Fluoroscopy may be used to confirm the position of one ormore of the needle, trocar, sheath or implantable device. Some methodsinclude the use of ultrasound for placement of the needle, trocar/sheathassembly and/or implantable devices. Some apparatus are provided toimprove imaging of the desired target site for positioning of theimplantable devices. Such apparatus may be used to deliver echogenicmaterial including anesthetic, analgesic or other types of material, orcombinations thereof, either serially or concomittently. Such apparatusmay be used for hydrodissection. In one embodiment, a needle delivers ananesthetic or analgesic and is employed for hydrodissection.

The implantation instruments for use in the methods include, but are notlimited to, a sharp tip trocar and a U-channel (or U-shaped) sheath andoptionally a blunt trocar and/or tissue expanding device (TED). Thesharp trocar/U-channel sheath creates a path for the implantable deviceand the hydrodissection prepares the tissue cavity for device insertion.A blunt trocar may replace the pointed trocar within the U-channelsheath for dilation near the bladder neck. In one embodiment, a blunttip trocar and a U-channel (or U-shaped) sheath and/or tissue expandingdevice (TED) is employed. Once the tip of the trocar is correctlylocated along the distal urethra near the bladder neck, the instrumentis uncoupled from the U-channel sheath and removed, leaving the sheathin place. The TED may then be used to dilate tissue at the site wherethe balloon is implanted by inserting and locking the TED in theU-channel sheath, then squeezing the TED handles to open the jaw,facilitating tissue dilation. The TED is then removed from the U-channelsheath.

In one embodiment, the implantable device delivered through the sheathconsists of a balloon, tube or bi-lumen tube and subcutaneous port. Thedevice may be formed from medical grade silicone elastomer. Theinjection port may be made from titanium covered in silicone elastomer.In one embodiment, the device is about 10 cm to about 15 cm, e.g., 12 cmor 14 cm, in overall length. The length of the tubing between theballoon and the titanium injection port allows for the difference inlength. The tubing that connects the balloon and the injection port hasone lumen used for inflation of the balloon and another for delivery ofthe implantable device into the tissue using a previously placed pushwire. The push wire may be made of medical grade stainless steel andprovides sufficient column strength to allow the device to be insertedto the correct position. Once the correct placement of the device hasbeen confirmed, the push wire is removed. In one embodiment, the balloonis spherical for the greatest tissue displacement effect in amedio-lateral direction with a volume variation of 0.5 milliliters up to8.0 milliliters per balloon. Two balloons are placed on either side ofthe urethra at the bladder neck. Each balloon may be filled with anisotonic mixture of sterile water and radiopaque contrast so that theballoon can be imaged at the bladder neck. The ports of the two devicesmay be placed in the posterior side of the scrotum so that percutaneousaccess by a needle of the ports for volume adjustment is easily attainedat a later time.

Thus, the invention provides a surgical instrument for penetratingtissue. For example, the instrument includes a trocar with a lumen, thetrocar having a distal end including a penetrating tip disposed at oneend thereof, and optionally a handle. The trocar may be formed by matingof two independent trocar portions, e.g., each along a centrallongitudinal axis, wherein the inner face of each portion is concave andthe mating forms a channel (lumen), e.g., of less than about 5 mm, 4 mm,3 mm, 2 mm or smaller in diameter, such as less than 1 mm in diameter.In one embodiment the lumen is about 0.5 mm to about 2 mm in diameter. Atrocar assembly may include an elongated U-shaped sheath dimensioned andstructured to removably receive the trocar. The sheath includes anelongated shaft in a U-shape, forming an interior, centrally disposedpassage or lumen. The elongated shaft allows for the penetrating tip atthe distal end of the trocar shaft to extend outward in the assembly.The penetrating instrument is designed and structured to effectivelycreate a small access opening by penetrating through underlying bodytissue of a patient in a manner which serves to separate and enlarge theopening created by a needle, as the penetrating tip and shaft of thetrocar/sheath assembly pass there-through. The overall structure,configuration, dimension and disposition of the penetrating instrumentis such as to accomplish an effective separation of the bodily tissuebeing penetrated with a minimal application of an inwardly directedlinear force. In doing so, the structure of the penetrating instrumentdilates the outer tissue in a manner which minimizes damage to thetissue. The penetrating tip of the trocar is cooperatively disposed,dimensioned and configured relative to and/or with the sheath. Thepenetrating tip includes a base and a distal extremity configured todefine an apex. The term apex includes a variety of differentconfigurations, which may vary from a sharpened point to a taperedlocale, as may be defined by the converging of the penetrating tip'sexterior surface from a base thereof and extending continuously to thedistal extremity or apex. In one embodiment of the present invention,the apex of the penetrating tip is spaced laterally outward or in anoff-set position relative to the central longitudinal access of thesheath shaft.

In one embodiment, the invention provides a method of preparing aconduit in body tissue for implanting an implantable device to improvecoaptation of the urethra at a target site for controllable coaptationof a patient's urethra, e.g., a male patient. The method includesplacing a small puncture in the perineum of the patient, passing aneedle through the puncture, while optionally delivering anestheticduring passage, to the target site under ultrasonic guidance, e.g.,biplanar ultrasound, placing a guidewire or stylet through or adjacentto the needle and withdrawing the needle. In one embodiment, a trocar,e.g., a mated trocar, and U-shaped sheath assembly is delivered over theguidewire or stylet to the target site. In one embodiment, the trocar isformed of at least two longitudinally mated portions that, onceassembled, form an inner lumen, and wherein the U-shaped sheath has aninterior space and is configured to fit over the outer circumference ofthe trocar. The trocar, and optionally the guidewire or stylet, isremoved and optionally the sheath is advanced. The implantable device isdelivered via the interior space of the U-shaped sheath. In oneembodiment, the method further comprises injecting echogenic fluid,e.g., water or an analgesic, at the target site adjacent the urethra. Inone embodiment, injecting includes hydrodissecting the target site withthe fluid to create a pocket for the implantable device. In oneembodiment, placing a small puncture includes placing a small puncturein the perineum using a spinal needle, hubless needle or a needle with aremovable hub, and passing the needle through to the target site. In oneembodiment, the assembly is delivered to the target site underultrasonic guidance. In one embodiment, the trocar and/or sheath is/areformed of stainless steel. In one embodiment, the trocar and/or sheathis/are formed of a synthetic polymer, e.g., polyethylene orpolypropylene. In one embodiment, the inner lumen of the assembled matedtrocar has a diameter of less than about 0.5 mm. In one embodiment, theinner lumen of the assembled trocar has a diameter of less than about1.0 mm.

In one embodiment, the invention provides a method of preparing aconduit in body tissue for implanting an implantable device to improvecoaptation of the urethra at a target site for controllable coaptationof a patient's urethra, i.e., a male or female patient. The methodincludes placing a small puncture in the perineum of the patient,passing a needle through the puncture, while optionally deliveringanesthetic during passage, to the target site under ultrasonic guidance,placing a guidewire or stylet through or adjacent to the needle andwithdrawing the needle. In one embodiment, a trocar, e.g., a tip capturetrocar, and U-shaped sheath assembly is delivered over the guidewire orstylet to the target site, and wherein the U-shaped sheath has aninterior space and is configured to fit over the outer circumference ofthe trocar. The tip capture trocar has a beveled receptacle at itsdistal tip such that it can attach to or house a proximal portion of aguidewire, stylet or needle and is slid down to the distal tip of theguidewire, stylet or needle, and which is retained in a slot along theside of the trocar. The trocar and the guidewire, stylet or needle areremoved, and optionally the sheath is advanced, before delivering theimplantable device via the interior space of the U-shaped sheath. In oneembodiment, the method further comprises injecting echogenic fluid,e.g., water or an analgesic, at the target site adjacent the urethra. Inone embodiment, injecting includes hydrodissecting the target site withthe fluid to create a pocket for the implantable device. In oneembodiment, placing a small puncture includes placing a small puncturein the perineum using a spinal needle, hubbed needle, hubless needle orremovable hub needle, and passing the needle through to the target site.In one embodiment, the assembly is delivered to the target site underultrasonic guidance. In one embodiment, the trocar and/or sheath is/areformed of stainless steel. In one embodiment, the trocar and/or sheathis/are formed of a synthetic polymer. In one embodiment, the inner lumenof the assembled trocar has a diameter of less than about 0.5 mm. In oneembodiment, the inner lumen of the assembled trocar has a diameter ofless than about 1.0 mm.

The invention also provides a method of mating a trocar. The methodincludes providing a first portion of a trocar and a second portion of atrocar, wherein the first portion has a recess at the distal end and thesecond portion has a protruding distal end, and wherein the innerlongitudinal face of each portion is concave; inserting the protrudingdistal end of the second portion into the recess of the first portion sothat the concave portions from each trocar portion form a lumen of lessthan about 1 mm in diameter, thereby forming an assembled trocar. In oneembodiment, the method includes inserting the assembled trocar into asheath. In one embodiment, the sheath is a U-shaped sheath. In oneembodiment, the method includes passing a liquid, gas, wire, tube,and/or other instrument through the lumen.

Also provided is a system for implanting an adjustable continence deviceinto a patient having a bladder with a bladder neck, the adjustablecontinence device comprising an adjustable balloon and a self sealingport. The system includes a trocar including a length and a width, thetrocar or one of the mated portions thereof is coupled to a handle andsized to extend from an incision in the patient to the bladder neck ofthe patient. In one embodiment, the trocar is formed of at least twomated portions that once assembled form an inner lumen, wherein oneportion has a recess at the distal end and the second portion has a tabextending at the distal end that is configured to fit into the recess.In one embodiment, the trocar is a tip capture trocar having a beveledreceptacle at its distal tip such that it can attach to a proximalportion of a guidewire, stylet or needle and a slot along its side; anda U-shaped sheath defining an interior space sized to removably andslidably receive the trocar, the sheath including a slot running atleast partially along a first portion, and tube shaped along a secondportion and defining a lumen along the second portion. In oneembodiment, the interior space is sized to slidably receive theadjustable continence device and a lumen of the device is sized toslidably receive a pushwire to push the adjustable continence devicethrough the interior space. In one embodiment, the trocar includes asharp tip at a distal end of the trocar, with the handle being at aproximal end of the trocar. In one embodiment, the handle is on one ofthe two mated parts. In one embodiment, the trocar includes a blunt tipat a distal end of the trocar, with the handle being at a proximal endof the trocar. In one embodiment, the trocar and/or the sheath includesstainless steel.

Further provided is a method for implanting a first adjustablecontinence device comprising an adjustable balloon and a self sealingport. The method includes inserting a trocar into a LT-shaped sheath toform an assembly. In one embodiment, the trocar is formed of at leasttwo mated portions that once assembled form an inner lumen, wherein oneportion has a recess at the distal end and the second portion has a tabthat is configured to fit into the recess. In one embodiment, the trocaris a tip capture trocar having at a distal end a receptacle for a tip ofa needle, guidewire or stylet and an off center opening. The U-shapedsheath is sized to removably and slidably receive the trocar, the sheathincluding a slot running at least partially along a first portion anddefining an interior space, and tube shaped along a second portion anddefining a lumen, wherein the interior space and lumen are sized toslidably receive the adjustable continence device. The assembly isinserted into a first incision and through tissue until a tip of thetrocar is proximal an exterior of a bladder of the patient and proximala bladder neck of the bladder; removing the trocar from the sheath;inserting a first implantable adjustable continence device through thesheath and into the patient proximal the exterior of the bladder andproximal the bladder neck of the bladder; adjusting the firstimplantable adjustable device using a syringe coupled to the selfsealing port; and removing the sheath from the patient. In oneembodiment, the adjustable device is inserted into the interior space ofthe sheath such that the self sealing port is not in the interior space.In one embodiment, the method includes pushing the implantableadjustable device into the patient using a pushwire that extends intothe lumen of the implantable device, e.g., removing the sheath while theimplantable device is inserted into the patient.

This Summary is an overview of some of the teachings of the presentapplication and is not intended to be an exclusive or exhaustivetreatment of the present subject matter. Further details about thepresent subject matter are found in the detailed description and theappended claims. The scope of the present invention is defined by theappended claims and their legal equivalents.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a sagittal or side view cross section showing male anatomy.

FIG. 2 is a side view cross section showing male anatomy after a radicalprostatectomy.

FIG. 3 is a top view showing approximate target sites of placement ofimplantable devices to improve coaptation of a urethra.

FIG. 4 is a view along the length of the urethra in the area ofimplantation showing approximate target sites of placement ofimplantable devices to improve coaptation of a urethra.

FIG. 5 is a side view cross section showing approximate placement ofimplantable devices in patients after radical prostatectomy.

FIG. 6 is a side view cross section showing approximate placement of animplantable device after Trans-Urethral Resection of the Prostate(TURP). “11” indicates where tissue has been removed.

FIG. 7 is a side view cross section showing approximate placement of animplantable device including their septa after Trans-Urethral Resectionof the Prostate (TURP).

FIG. 8 is a side view cross section showing approximate placement of animplantable device including their septa after radical prostatectomy.

FIG. 9 shows one application of the present subject matter to a patient.

FIG. 10 shows a patient in the lithotomy position. A Foley catheter isinserted and the bladder is filled with 40-50 mL of saline solution. Twohorizontal 0.5- to 1-cm skin incisions are made in the perineum about 1cm lateral to the median line and about 1.5 cm above the rectum.

FIG. 11 shows insertion of a needle proximal to a target site. Deeplocal anesthesia is administered with the needle, e.g., a 20-gaugespinal needle, which is inserted through skin incisions and thendirected bilaterally to the vesicourethral anastomosis under biplanartransrectal ultrasound guidance (as shown in the box). A linear probemonitors advancement of the 20-gauge spinal needle towards the bladderneck, while the convex probe monitors the distance from the urethra. Theanaesthetic is released along the needle path in the subcutaneous tissuein the pelvic diaphragm and laterally to the anastomosis, creating thespace for an implanted device by a mechanism of hydrodissection. Aguidewire, e.g., with a tip, is placed through the needle. The tip,e.g., a J-tip, extends beyond the tip of the needle. B=bladder; PB=pubicbone; PD=pelvic diaphragm; R=rectum.

FIG. 12 illustrates introduction of a trocar/sheath assembly undertransrectal ultrasound (TRUST guidance (as shown in the box). Thesharp-tipped, removable trocar contained within a U-shaped sheath isinserted over the guidewire. A rotating action (twisting motion) may beemployed to perforate the pelvic diaphragm and advance the trocar overthe wire towards the hydrodissected tissue, e.g., scar tissue, at thelevel of anastomosis on one side of the bladder neck.

FIG. 13 illustrates trocar removal, leaving the U-shaped sheath inplace. The internal channel of the sheath is lubricated using sterilegel and with the help of a push wire, the implantable device is passedalong the sheath into position at the bladder neck. The balloon isinflated with 1 mL normal saline, e.g., 0.9% saline, solution via thetitanium port. Transrectal ultrasound is used to confirm correct balloonplacement, as shown in the box. B=bladder; PB=pubic bone; PD=pelvicdiaphragm; R=rectum.

FIGS. 14-19 show exemplary slotted trocars and sheaths, and assemblythereof. FIG. 14 shows the mating of portions of a slotted trocar andFIG. 14 shows a sheath. The portion of the trocar at the top of FIG. 14(and the bottom of FIG. 15) has a tab at the distal end and aligns withthe other portion, e.g., between the handles. An enlarged view of thedistal ends of each portion is shown in FIG. 16 and FIG. 17. FIG. 18shows a slotted trocar inserted into the lumen of a sheath with a wiredepicted to illustrate the lumen of the trocar. FIG. 19 illustrates thatthe lumen of a trocar may extends from a proximal end to a distal end.

FIG. 20 shows exemplary slotted trocars and sheaths and TED.

FIG. 21A illustrates one example of a tip capture slotted trocar andsheath, and the assembly thereof.

FIG. 21B shows an expanded view of the tip of a tip capture trocar.

DETAILED DESCRIPTION

The following detailed description of the present invention refers tosubject matter in the accompanying drawings which show, by way ofillustration, specific aspects and embodiments in which the presentsubject matter may be practiced. These embodiments are described insufficient detail to enable those skilled in the art to practice thepresent subject matter. References to “an”, “one”, or “various”embodiments in this disclosure are not necessarily to the sameembodiment, and such references contemplate more than one embodiment.The following detailed description is, therefore, not to be taken in alimiting sense, and the scope is defined only by the appended claims,along with the full scope of legal equivalents to which such claims areentitled.

FIG. 1 is a sagittal or side view cross section showing male anatomy.The bladder 1 is connected to the urethra 2 which exits at the penis 4.A prostate gland 3 surrounds the urethra 2 near the base of the bladder4. The urethral lumen within the prostate is shown as being constrictedeither by Benign Prostatic Hyperplasia (BPH) which is treated by TURP orprostate cancer which is treated by radical prostatectomy. Also shown isthe scrotum 5 and perineum 8, which is the skin behind the scrotum, theanus 6 which is the opening to the rectum 7, and the pubic bone 9.

FIG. 2 is a side view cross section showing male anatomy after a radicalprostatectomy. In some embodiments, the prostate is removed duringradical prostatectomy and the cut urethra is brought up and aurethral-vesical anastomosis 17 is provided to the bladder neck withsutures or staples. Removal of the prostate can damage the surroundingor adjacent tissue including the urinary sphincter and/or itsenervation, resulting in incontinence due to a loss of coaptation of theurethra. One way to increase the coaptation is through the use of tissuebulking devices, such as the implantable devices described in U.S. Pat.Nos. 6,045,498, 5,964,806, 6,579,224, and 6,419,624 and their relatedpatents and applications, the descriptions of which are herebyincorporated in their entirety.

FIG. 3 is a top view of the bladder 1 and urethra 2 showing approximatetarget sites of placement of implantable devices 10 to improvecoaptation of a urethra, according to one embodiment of present subjectmatter. The orientation of the y-axis is along the direction of theurethra 2 in the approximate location of implantation. The location isnear the bladder neck and urethral vesical anastomosis in the case ofradical prostatectomy or further down the urethra at the apex of theprostate after TURP.

FIG. 4 is a view along the length of the urethra 2 in the area ofimplantation (or along the y-axis) showing approximate target sites ofplacement of implantable devices 10 to improve coaptation of a urethra,according to one embodiment of present subject matter. One of thedifficulties addressed by the teachings provided herein is to assist inthe proper location of the implantable devices 10. In particular, theaccurate placement of the implantable devices 10 along the z-axis(sagittal view) is facilitated by the teachings of the present subjectmatter.

FIG. 5 is a side view cross section showing approximate placement ofimplantable devices 10 in patients after radical prostatectomy,according to one embodiment of the present subject matter. It isunderstood that implantable devices may be placed in different positionswithout departing from the scope of the present subject matter. Thus, itis understood that the positions shown in the figures are intended todemonstrate the present subject matter, but are not intended in anexclusive or limited sense.

One advantage of a biplanar ultrasonic rectal probe is that it canprovide planar images of tissue both longitudinally in the XY plane andradially from the rectal ultrasound probe in the rectum parallel to theurethra in the XZ plane. This facilitates placement of the devices atthe target site with respect to the position of the urethra and bladder.

FIG. 6 is a side view cross section showing approximate placement ofimplantable devices, according to one embodiment of the present subjectmatter. For patients with a full or partial prostate gland 3 after TURP,the expandable portion of each implantable device 10 can be placed alongthe urethra near the apex of the prostate 18 to increase tissue bulkingand coaptation in that area. An ultrasonic probe 20 can be inserted intothe rectum 7 via the anus 6 to assist in imaging the locations of theimplantable devices 10. FIG. 6 shows a prostrate gland 3 after TURP andareas 11 indicating resected portion of the prostrate.

FIG. 9 shows one application of the present subject matter to a patient.An ultrasonic rectal probe 20 is used in conjunction with a Foleycatheter 21 placed in the urethra with the Foley balloon 22 inflated inthe bladder 1 to assist in visualizing the bladder neck and urethra 2.In such applications a doctor can rotate the rectal probe 20 to get apicture of the placement of devices with respect to the urethra in anaxial segment. By rotating the probe the doctor can image the bladderneck, proximal urethra and the Foley balloon 22 sitting in the bladderneck. The doctor can also get an image of any delivery devices 30 usedto deliver fluid to the target location of where the expandable portionof the implant and delivery instruments for the device itself are to belocated. In various applications water can be used. Water is echogenic,so it better shows the target location of the expandable portion of theimplantable device 10. In various uses the water is combined with ananalgesic, such as lidocaine. In some embodiments, water with or withoutan analgesic can be injected at the site intended for the expandableportion of the implantable device 10 to create a pocket in the tissue sothat the expandable portion will tend to stay in that position duringand after inflation without migrating. This process is called“hydrodissection.”

In one embodiment, the following process is employed to image the targetlocation and accurately place the devices. It is understood thatdifferences in method steps, order of steps, and apparatus can be madewithout departing from the scope of the present subject matter.

-   -   A Foley catheter is inserted into the urethra and the Foley        balloon is inflated with water in the bladder neck.    -   An ultrasonic probe is inserted into the rectum of the patient.    -   The doctor uses the ultrasonic probe to image the urethra and        bladder neck using the echogenetic Foley balloon as a landmark.    -   A small puncture in the skin in the perineum is made.    -   The doctor chooses a target tissue site near the bladder neck        for radical prostatectomy or the apex of the prostate for TURP        for placement of analgesic and fluid for hydrodissection of the        targeted tissue site.    -   The doctor inserts a delivery device such as a needle into the        small puncture of the perineum and, under ultrasonic visual        guidance alternating between radial and longitudinal views as        needed, tunnels through the tissue adjacent the urethra. As that        delivery device is advanced the doctor may inject anesthetic or        analgesic along the path, thus allowing the procedure to be done        under local anesthesia.    -   Once at the intended delivery site more fluid can be injected to        create a bolus for hydrodissection of the tissue in preparation        for delivery of the expandable device.    -   A delivery device, e.g., a slotted trocar/sheath assembly as        described herein, is inserted, and used to deliver the        implantable device.    -   The expandable portion of the implantable device is accurately        positioned at the target site.    -   The implantable device is then adjusted for proper coaptation.    -   For devices with a septum, the septum is placed under the skin.        If the procedure is done under local anesthesia the site for the        septum is first anesthetized with analgesic via a needle and        syringe. Such devices allow for straightforward postoperative        adjustment of the urethral coaptation    -   The other side of the urethra is then treated using the same or        similar procedure.

It is understood that a doctor may manipulate the delivery device withone hand and the ultrasound with the other to get continuous imaging andfeedback. The doctor can also continuously switch back and forth betweena radial view and a longitudinal view using, e.g., biplanar ultrasound,to ensure that the delivery device and/or implantable device is at theright distance along the urethra or from the urethra.

Various delivery devices in various embodiments can be used to introducethe echogenic fluid and place the expandable portion of the implantabledevices.

It is understood that a variety of different trocar, guidewire, stylet,needle, and/or sheath combinations may be used without departing fromthe scope of the present subject matter. Furthermore, in variousembodiments different fluid channels and Luer connections may beemployed to deliver fluid to the intended target site. Additionally,delivery methods using wires placed using slotted sheaths, trocars,and/or other assemblies may be employed to deliver implantable devicesto the intended target sites. It is also understood that certainembodiments of implantable devices may include openings or aperturesthat accommodate a pushrod or other wire to place the implantabledevices in tissue at desired target sites. It is further contemplatedthat one or more implantable devices can be used to enhance coaptationand that the number of devices is not limited to those demonstratedherein. It is understood that delivery devices of various dimensions maybe employed to achieve proper placement of the implantable device andsepta of such devices.

In one embodiment, the initial approach to the delivery site for theexpandable element and hydrodissection at the site is made with a spinalneedle. The needle is then used to deliver echogenic fluid and/oranesthetic or analgesic (if needed). The needle is then withdrawn andreplaced, again under guidance, with a device for delivering. In oneembodiment, this device includes a pointed trocar within a removablesheath. In one embodiment, the trocar is hollow along its full length.In some embodiments, the sheath remains while the trocar is removed toprovide a tool for delivery of the implantable device. In someembodiments a splittable sheath is used. Other embodiments are possiblewithout departing from the scope of the present subject matter.

FIG. 7 is a side view cross section showing approximate placement ofimplantable devices 10 including their septa 14 (in such embodiments),after TURP according to one embodiment of the present subject matter. Itis understood that the septa 14 can be placed in various tissuelocations, such as the scrotum 5 or somewhere in the perineal region 8.Subcutaneous placement of the septa provide for postoperative adjustmentof the implantable devices by accessing the septum through the skin witha hypodermic needle. Coaptation can be adjusted by any of the proceduresprovided in the references incorporated by reference herein. Forexample, a cystoscope can be inserted into the urethra 2 to measurecoaptation. Other devices, placements, and approaches are possiblewithout departing from the present subject matter.

FIG. 8 is a side view cross section showing approximate placement ofimplantable devices 10 including their septa 14 (in such embodiments),after radical prostatectomy according to one embodiment of the presentsubject matter. It is understood that the septa 14 can be placed invarious tissue locations, such as the scrotum 5 or somewhere in theperineal region 8. Subcutaneous placement of the septa provide forpostoperative adjustment of the implantable devices. Coaptation can beadjusted by any of the procedures provided in the referencesincorporated by reference herein. For example, a cystoscope can beinserted into the urethra 2 to measure coaptation. Other devices,placements, and approaches are possible without departing from thepresent subject matter. Various embodiments include components that aredisposable, that is that are sterilizable but not necessarilyresterilizable. Such components may be made from polymers such aspolyethylene, polypropylene or polytetrafluoroethylene.

A trocar includes an elongate member (shaft) and a handle portion. Invarious embodiments, the trocar is reusable (e.g., can be resterilized).The elongate member, in various embodiments, is sterilizable. Inadditional embodiments, the handle portion is also sterilizable. Inanother embodiment, the trocar includes steam sterilizable components.Various embodiments incorporate materials known to provide for suchfunction, such as surgical grade stainless steel. Multiple embodimentsare contemplated by the present subject matter. In each embodiment, oneor more materials are used in constructing elongate member. In eachembodiment, one or more materials are used in constructing handleportion.

The trocar has a proximal end and a distal end, in various embodiments.In one embodiment, a handle portion is located at a proximal end. In oneembodiment, the trocar includes a sharp, e.g., beveled, tip, at a distalend. The tip is useful for penetrating tissue of a patient, according toone embodiment, such as when a doctor grasps the handle and maneuversthe trocar, distal portion first, through an incision and to an implantsite located proximal a bladder neck of a patient.

A sheath includes an elongate member (shaft) and a handle portion. Theelongate member is trough (U- or C-) shaped across its diameter, in oneembodiment. In, various embodiments, the elongate member includes tubingwhich has a slot opening running at least part of the way down itslength. The elongate member has a cross section which is curved invarious embodiments. As such, these embodiments define an interior spaceof the sheath. In various embodiments, a removable trocar is sized forslidable disposition in the elongate member of the sheath, via anopening in the handle of the sheath. In various embodiments, one or morematerials are used in constructing elongate member of the sheath. Ineach embodiment, one or more materials are used in constructing handleportion of the sheath. In various embodiments, materials include, butare not limited to, stainless steel and other materials not expresslyrecited herein.

In one embodiment, the trocar shaft (housing), once assembled if it is amated slotted trocar (FIGS. 14-19), has an elongate shape with an innerlumen suitable for passage, e.g., of a wire. In various exampleembodiments, the trocar is assembled from two or more longitudinallymatched (mated) pieces (portions or parts). For example, one portion mayhave a distal receptacle (nose) (FIG. 16) for the distal end (tab) ofthe second portion (FIG. 17) and an optional handle. In another example,one portion may include a distal receptacle (nose) for the distal end(tab) of the second portion which second portion optionally includes ahandle. However, other various example embodiments may include matingconfigurations of multiple sections of instruments having the samediameter. This mate or self-alignment of the first and second trocarportions may be accomplished by other means familiar to one skilled inthe art such as, but not limited to, a tapered diameter trocar, acircular or rectangular funnel shaped endpoint on the receiving trocar.

The trocar is inserted into a U-shaped sheath (FIG. 18), and a tube,wiring, and/or other device(s) may be routed through the lumen of thetrocar (FIG. 19). This allows for a continuous subcutaneous path throughfirst and second trocar portions for the placement of the aforementionedtubing, wiring, and/or any other physical connection media between thefirst and second incisions. After the trocar portion is removed and thesheath remains and is employed to deliver the implantable device. Othermechanical, electromechanical, or electronic guidance means can beplaced on or around the trocar to aid positioning before or duringblind-mating or self-alignment.

The methods of using the slotted trocar/sheath assembly includeadministering an anesthetic, e.g., a local anesthetic. The methods alsoinclude preparing radiopaque contrast media such that the media can beused for radiographic monitoring during surgery. In one embodiment,normal saline may be used for use. Saline, contrast, and other materialsare used to expand an implantable adjustable expandable genitourinarydevice. One embodiment includes cleaning and sterilizing surgical tools.

Various embodiments include inserting a trocar into a sheath. In variousembodiments, the doctor is to insert the trocar/sheath assembly into anincision. In various embodiments, when the tip of the implantationinstrument reaches the target site below the bladder neck, the trocar isremoved. In one embodiment, this is done while maintaining position ofsheath tip at desired adjustable continence balloon implant location.

In one embodiment, the doctor has access to a variety of elongateimplantable devices, such as those described in U.S. Pat. Nos.6,045,498, and 5,964,806, which are incorporated herein by reference. Inone embodiment, three devices of different lengths are provided,although more or less than three devices having different lengths can beprovided. In various embodiments, based on the surgery and the relevantphysiology, the doctor selects an adjustable continence device with theappropriate length such that a balloon of the device can be locatedproximal the bladder, and the adjustment chamber including a septum,such as a self sealing septum, can be located proximal the incision.

One embodiment includes inserting an implantable adjustable devicethrough the sheath and into the patient proximal the exterior of thebladder and proximal the bladder neck of the bladder. Variousembodiments advance the adjustable continence device with the balloondeflated through the sheath to the selected position using a push wire.In one embodiment, it is helpful to ensure the push wire is fullyinserted in the adjustable continence device. In one embodiment, theposition of the tip of the device can be confirmed by, for example,fluoroscopy, cystoscopy or palpation. The tip of the device ispositioned underneath the bladder neck, in one embodiment.

FIG. 20 shows, among other things, a tissue expanding device for use inthe methods.

Various methods include pulling the sheath back about 2 centimeters suchthat the balloon is clear of the sheath. This is to, in part, ensurethat the balloon is not damaged during inflation. Various embodimentsinclude, adjusting the implantable adjustable device. In variousembodiments, the doctor penetrates the port septum with a needle of asyringe, such as a 23 gauge non-coring needle on the syringe, andinflates the adjustable continence balloon with fluid, such as withapproximately 1 milliliter of normal saline or isotonic contrastsolution. In embodiments using x-ray visualization or ultrasound, thedoctor can view the balloon assuming a spherical shape. One embodimentincludes removing the sheath completely from the patient beforeinflation.

In one embodiment using two or more implantable adjustable devices, thedoctor is to leave the push wire in place and to perform a similarprocedure for other devices. In embodiments using two devicescontralateral to another with respect to the patient, the doctor is toproceed in the same way with the contralateral side.

In examples where it is possible, the doctor is to confirm symmetricalpositioning of the adjustable continence balloons with respect to theurethra such as by radiology or by ultrasound. When a doctor determinesthat the location of implantable devices is acceptable, they can removethe push wires from both adjustable continence devices after ballooninflation.

When both adjustable continence devices are in position and have beeninflated, the doctor can remove the Foley catheter, if one was used. Inone embodiment, the doctor can check for continence with a stress test.If the patient remains incontinent after the stress test, one embodimentallows for an increase in the volume of one or both balloons inincrements, such as by 0.5 milliliter increments using the saline orisotonic contrast solution until continence is confirmed. Some devicesprovide for up to 2.0 milliliter per balloon, but the present subjectmatter is not so limited. For example, the balloon may initially haveabout 1.5 milliliters per balloon and then increments of, for example 2milliliters, are added up to about 8 to 12 milliliters per balloon. Insome optional examples, the doctor confirms the absence of urethral orbladder injury by cystoscopic examination.

Various embodiments provide for the doctor to create a pocket in thecontralateral side in the same manner. For a male patient, a pocket iscreated in the scrotum to receive the port and a pocket is created inthe contralateral side to receive the other port. In some of theseembodiments, the doctor places the remaining adjustable continencedevice port in this pocket. In one embodiment, the doctor checks toverify that the tubing of the adjustable continence devices is notkinked unacceptably.

Exemplary Transrectal Ultrasound (TRUS) Assisted Over the Wire (OTW)Implantation Procedure.

The patient is placed in the lithotomy position and the lower abdomen,genitalia, perineum, and the perianal area are disinfected. A 14- or16-Ch Foley catheter is inserted in the bladder, which is filled with40-50 mL of saline solution to clearly visualize the urethra and thebladder neck with TRUS. The scrotum is held above the perineum withtape. The anal ring is isolated from the perineum with a drape and TRUSis performed using a 7.5-MHz linear probe and a small convex probe. Whenlocal anesthesia only is used, 10 mL of ropivacaine 7.5 mg/mL may beadministered with a regular 20-gauge needle in skin and subcutaneoustissue at 1-2-cm intervals bilaterally around the intended perinealincisions. Two horizontal 0.5-1-cm skin incisions may be made in theperineum about 1 cm lateral to the median line and about 1.5 cm abovethe rectum (FIG. 10). Deep local anesthesia is then to be administeredwith 20 mL of ropivacaine 7.5 mg/mL. For example, a 20-gauge spinalneedle is inserted through the skin incisions and directed bilaterallyto the vesicourethral anastomosis under biplanar (e longitudinal tocoronal) TRUS guidance (FIG. 11). The linear probe monitors advancementof the 20-gauge spinal needle towards the bladder neck, while the convexprobe is used to monitor the distance from the urethra. The anestheticis released along the needle path in the subcutaneous tissue, in thepelvic diaphragm, and laterally to the anastomosis, creating the spacefor implantable device by hydrodisseaion. A guidewire or stylet isplaced next to or through the needle, and the needle is removed.

Under TRUS guidance, a trocar and sheath assembly, e.g., a sharp orblunt tipped, removable trocar, e.g., a mated trocar or a tip capturetrocar (FIGS. 21A and 21B), contained within a U-shaped sheath, isinserted over the wire through the skin incision. A twisting motion isemployed to perforate the pelvic diaphragm and advance the trocartowards the hydrodissected scar tissue at the level of anastomosis onone side of the bladder neck. The position of the trocar and sheath maybe confirmed by TRUS (FIG. 12). The trocar and wire are removed, leavingthe U-shaped sheath in place. During this maneuver the sheath may begently advanced about 0.5 cm to occupy the space created by the trocartip.

The internal channel of the sheath is then lubricated using a sterilegel. With the help of a push wire, an implantable device is passed alongthe sheath into position at the bladder neck. The sheath is withdrawnapproximately 2 cm to permit balloon expansion as it is inflated with,for instance, 1 mL normal saline solution via the titanium port (FIG.13). TRUS may be used to confirm correct balloon placement in all planes(linear probe to establish proximity to the bladder neck and convexprobe to assess balloon position laterally in relation to the urethra).Exemplary balloon placement is considered as being 5-10 mm proximal tothe bladder neck and 2-5 mm lateral from the urethra. In one embodiment,the balloons are placed at 9 o'clock and 3 o'clock in relation to theurethra to create a triangular coaptation of the urethra between the twoballoons and the symphysis pubis. The push wire is then removed. Usingscissors or a Kelly clamp, a subcutaneous parascrotal tunnel isfashioned to allow placement of the conduit tube and titanium port. Thetunnel should be sufficiently sized to ensure that the balloon tubing isnot looped or kinked and the port can lie in a supine position. Theprocedure may be repeated on the contralateral side. The incisions areclosed in two layers with 4-0 resorbable sutures.

The trocar and/or sheath may be reusable (resterilizable). The trocar,e.g., mated, bore hole or tip capture trocar, or the portions of a matedtrocar, or sheath are cleaned and sterilized before and after each use.For example, the trocar and sheath components are immersed and soaked inwarm tap water (20-40° C.) and pH neutralized enzymatic detergent for 10minutes. For 5 minutes, all individual components are scrubbed with asoft bristle brush to visually remove soil. For 30 seconds, thecomponents are thoroughly rinsed with warm water (20-40° C.). For 10minutes, the components are ultrasonically cleaned in room temperaturepurified water and pH neutral enzymatic detergent. For 1 minute, thecomponents are thoroughly rinsed with room temperature purified water.The components are dried using low tinting, non-abrasive soft cloth. Forsterilization, the components are steam sterilized using a prevacuumcycle at 132°-135° C. (275° F.) for a minimum of three (3) minutes.Prior to use, the instrument is reassembled by placing the “tab” of oneportion of the trocar into the nose of the other portion of the trocar,and the tabbed portion is lowered into the handle, after which theassembled slotted trocar is inserted in the U-channel sheath.

In one embodiment, the invention thus provides a slotted trocar for“over the wire” use with a sheath and a needle, for assisting in theplacement of an implantable device adjacent a body lumen. In oneembodiment, a needle, e.g., a spinal needle, e.g., a 20 gauge needle, isinserted into an incision adjacent a body lumen and the needle isadvanced using TRUS that includes a linear probe and a convex probe.Anesthetic is delivered through the needle along the path of advancementand once the needle is placed at target site for an implantable deviceplacement using TRUS, hydrodissection is employed to create space forthe implantable device. The needle is used to place a guidewire orstylet, and then the needle is withdrawn leaving the guidewire or styletwhich is used to guide the assembled trocar and a channeled sheath(“over the wire”) into the space previously occupied by the needle. Thetrocar may have a sharp distal end and force is employed to advance theassembled trocar/sheath combination. In one embodiment, the trocar mayhave a blunt distal end and force is employed to advance the assembledtrocar/sheath combination. TRUS is employed to verify position of thetrocar/sheath device. The trocar is withdrawn and the sheath is slightlyadvanced to occupy the space created. The inner channel of the sheath islubricated prior to advancing the implantable device in the channel,e.g., using a push wire. The sheath is retracted slightly about 1-2 cm,to allow for balloon expansion.

In one embodiment, a slotted trocar is formed by assembly of at leasttwo trocar parts. Each part has a convex outer surface and a concaveinner surface which inner surface once assembled, forms a channel(lumen) of less than about 1 mm (e.g., 0.04 inches or less) in diameterfor a guidewire, e.g., one which may be about 0.035 to 0.038 inches indiameter. In one embodiment, the trocar is formed of a material that canbe sterilized and reused, e.g., stainless steel. After assembly of thetrocar, it is inserted into a sheath with a U-shaped channel. The sheathmay formed of a material that can be sterilized and reused, e.g.,stainless steel.

Exemplary Transrectal Ultrasound (TRUS) Assisted Over the Needle (OTN)Implantation Procedure.

The patient is placed in the lithotomy position and the lower abdomen,genitalia, perineum, and the perianal area are disinfected. A 14- or16-Ch Foley catheter is inserted in the bladder, which is filled with40-50 mL of saline solution to clearly visualize the urethra and thebladder neck with TRUS. The scrotum is held above the perineum withtape. The anal ring is isolated from the perineum with a drape and TRUSis performed using a biplanar probe having a 7.5-MHz linear probe and asmall convex probe. When local anesthesia only is used, 10 mL ofropivacaine 7.5 mg/mL may be administered with a regular 20-gauge needlein skin and subcutaneous tissue at 1-2-cm intervals bilaterally aroundthe intended perineal incisions. Two horizontal 0.5-1-cm skin incisionsmay be made in the perineum about 1 cm lateral to the median line andabout 1.5 cm above the rectum. Deep local anesthesia is then to beadministered with 20 mL of ropivacaine 7.5 mg/mL. For example, a20-gauge needle, e.g., one having a hub adapted for a syringe, aremovable hub or a hubless needle, is inserted through the skinincisions and directed bilaterally to the vesicourethral anastomosisunder multiplanar TRUS guidance. The linear probe monitors advancementof the 20-gauge spinal needle towards the bladder neck, while the convexprobe is used to monitor the distance from the urethra. The anestheticis released along the needle path in the subcutaneous tissue, in thepelvic diaphragm, and laterally to the anastomosis, creating the spacefor implantable device by hydrodissection.

Under TRUS guidance, a trocar and sheath assembly, e.g., bore hole,slotted or tip capture trocar, contained within a U-shaped sheath, isinserted over or adjacent to the needle through the skin incision. Inone embodiment, an assembly having a bore hole trocar or slotted trocaris inserted over or adjacent to a hubless needle or a needle with aremovable hub (so that the internal lumen can pass over the needle). Inone embodiment, an assembly having a tip capture trocar is inserted overor adjacent to a hubbed needle. A twisting motion is employed toperforate the pelvic diaphragm and advance the trocar towards thehydrodissected scar tissue at the level of anastomosis on one side ofthe bladder neck. The position of the trocar and sheath may be confirmedby TRUS. The trocar and the needle are removed, leaving the U-shapedsheath in place. During this maneuver the sheath may be gently advancedabout 0.5 cm to occupy the space created by the trocar tip.

The internal channel of the sheath is then lubricated using a sterilegel. With the help of a push wire, an implantable device is passed alongthe sheath into position at the bladder neck. The sheath is withdrawnapproximately 2 cm to permit balloon expansion as it is inflated with,for instance, 1 mL 0.9% saline solution via the titanium port. TRUS maybe used to confirm correct balloon placement in all planes (linear probeto establish proximity to the bladder neck and convex probe to assessballoon position laterally in relation to the urethra). Exemplaryballoon placement is considered as being 5-10 mm proximal to the bladderneck and 2-5 mm lateral from the urethra. In one embodiment, theballoons are placed at 9 o'clock and 3 o'clock in relation to theurethra to create a triangular coaptation of the urethra between the twoballoons and the symphysis pubis. The push wire is then removed. Usingscissors or a Kelly clamp, a subcutaneous parascrotal tunnel isfashioned to allow placement of the conduit tube and titanium port. Thetunnel should be sufficiently sized to ensure that the balloon tubing isnot looped or kinked and the port can lie in a supine position. Theprocedure may be repeated on the contralateral side. The incisions areclosed in two layers with 4-0 resorbable sutures.

The trocar and/or sheath may be reusable (resterilizable). The trocar orthe portions of the mated slotted trocar or sheath are cleaned andsterilized before and after each use. For example, the trocar and sheathcomponents are immersed and soaked in warm tap water (20-40° C.) and pHneutralized enzymatic detergent for 10 minutes. For 5 minutes, allindividual components are scrubbed with a soft bristle brush to visuallyremove soil. For 30 seconds, the components are thoroughly rinsed withwarm water (20-40° C.). For 10 minutes, the components areultrasonically cleaned in room temperature purified water and pH neutralenzymatic detergent. For 1 minute, the components are thoroughly rinsedwith room temperature purified water. The components are dried using lowtinting, non-abrasive soft cloth. For sterilization, the components aresteam sterilized using a prevacuum cycle at 132°-135° C. (275° F.) for aminimum of three (3) minutes. Prior to use, the instrument isreassembled by placing the “tab” of one portion of the trocar into thenose of the other portion of the trocar, and the shaft is lowered intothe handle, after which the assembled slotted trocar is inserted in theU-channel sheath.

In one embodiment, the invention thus provides a slotted trocar for“over the needle” use with a sheath, for assisting in the placement ofan implantable device adjacent a body lumen. In one embodiment, aneedle, e.g., a spinal needle, e.g., a 20 gauge needle, is inserted intoan incision adjacent a body lumen and the needle is advanced using TRUSthat includes a linear probe and a convex probe. Anesthetic is deliveredthrough the needle along the path of advancement and once the needle isplaced at target site for an implantable device placement using TRUS,hydrodissection is employed to create space for the implantable device.The needle is used to guide the trocar and a channeled sheath into thespace previously occupied by the needle. The trocar may have a sharpdistal end and force is employed to advance the assembled trocar/sheathcombination. In one embodiment, the trocar may have a blunt distal endand force is employed to advance the assembled trocar/sheathcombination. TRUS is employed to verify position of the trocar/sheathdevice. The trocar and needle are withdrawn and the sheath is slightlyadvanced to occupy the space created. The inner channel of the sheath islubricated prior to advancing the implantable device in the channel,e.g., using a push wire. The sheath is retracted slightly about 1-2 cm,e.g., using TRUS, to allow for balloon expansion.

In one embodiment, the slotted trocar is formed by assembly of at leasttwo trocar parts. Each part has a convex outer surface and a concaveinner surface which inner surface once assembled, forms a channel(lumen) of less than about 1 mm (about 0.05 inches or less, e.g., 0.04inches or less) in diameter for a guidewire, e.g., one which may beabout 0.035 to 0.038 inches in diameter. In one embodiment, the trocaris formed of a material that can be sterilized and reused, e.g.,stainless steel. After assembly of the trocar, it is inserted into asheath with a U-shaped channel. The sheath may formed of a material thatcan be sterilized and reused, e.g., stainless steel.

While the method and apparatus provided herein are demonstrated forapplication to the male, it is understood that they are applicable tofemale applications as well. Likewise they are applicable in general toprovide coaptation to other lumens within the body such as the analcanal and rectum or the esophagus.

It is understood that various implantable devices may be employed. Theimaging of such devices may be enhanced by adding echogenic coating orelements within the expandable portion. Various imaging methods mayinclude temporarily filling the expandable portion with air to provideenhanced visibility via ultrasound. Other approaches are possiblewithout departing from the scope of the present subject matter.

This application is intended to cover adaptations and variations of thepresent subject matter. It is to be understood that the abovedescription is intended to be illustrative, and not restrictive. Thescope of the present subject matter should be determined with referenceto the appended claim, along with the full scope of legal equivalents towhich the claims are entitled.

What is claimed is:
 1. A method for implanting an implantable adjustabledevice to improve coaptation of the urethra at a target site forcontrollable coaptation of a patient's urethra, comprising: delivering atrocar and a U-shaped sheath assembly over or adjacent to a needlepassed through a small puncture in the perineum of the patient, whileoptionally delivering anesthetic or analgesic during passage, to thetarget site under ultrasonic guidance, while the needle is at the targetsite and removing the trocar and the needle, while leaving the sheath atthe target site, wherein the U-shaped sheath has an interior space andis configured to fit over the outer circumference of the trocar andwherein the trocar is formed of at least two longitudinally matedportions that, once assembled, form an inner lumen, wherein a firstportion of the trocar has a recess at a distal end and a second portionof the trocar has a tab extending at the distal end that is configuredto fit into the recess; and delivering the implantable adjustable devicevia the interior space of the U-shaped sheath.
 2. The method of claim 1,further comprising injecting echogenic fluid at the target site adjacentthe urethra, wherein the echogenic fluid comprises an anesthetic oranalgesic fluid.
 3. The method of claim 1, further comprising injectinga fluid at the target site including hydrodissecting the target sitewith the fluid to create a pocket for the implantable device.
 4. Themethod of claim 1, wherein the U-shaped sheath assembly is delivered tothe target site under ultrasonic guidance.
 5. The method of claim 1,wherein the trocar and the U-shaped sheath assembly are placed proximalto an exterior of a bladder of the patient and proximal to a bladderneck of the bladder.
 6. The method of claim 1, wherein the implantabledevice comprises an adjustable device comprising an adjustable balloonconnected to a self sealing port via a conduit.
 7. The method of claim1, wherein the needle that is employed with the trocar is a hublessneedle or a needle with a removable hub.
 8. The method of claim 1,wherein the needle is a hubbed needle.
 9. The method of claim 1, whereinthe trocar is formed of material that is steam sterilizable.
 10. Amethod for implanting an implantable adjustable incontinence device toimprove coaptation of the urethra at a target site for controllablecoaptation of a patient's urethra, comprising: placing a small puncturein the perineum of the patient, passing a needle through the puncture,while optionally delivering anesthetic or analgesic during passage, tothe target site under ultrasonic guidance; placing at a position aguidewire or stylet through or adjacent to the needle, while the needleis at the target site, withdrawing the needle, while leaving theguidewire or stylet at the position, delivering a trocar and a U-shapedsheath assembly over the guidewire or stylet to the target site, afterthe needle is withdrawn, and removing the trocar, while leaving thesheath at the target site, wherein the U-shaped sheath has an interiorspace and is configured to fit over the outer circumference of thetrocar; and delivering the implantable adjustable device via theinterior space of the U-shaped sheath.
 11. The method of claim 10,further comprising injecting echogenic fluid at the target site adjacentthe urethra, wherein the echogenic fluid comprises an anesthetic oranalgesic fluid.
 12. The method of claim 10, further comprisinginjecting a fluid at the target site including hydrodissecting thetarget site with the fluid to create a pocket for the implantabledevice.
 13. The method of claim 10, wherein the U-shaped sheath assemblyis delivered to the target site under ultrasonic guidance.
 14. Themethod of claim 10, wherein the guidewire or stylet is placed throughthe needle.
 15. The method of claim 10, wherein the inner lumen of thetrocar has a diameter of less than about 1.0 mm.
 16. The method of claim10, wherein the trocar and the U-shaped sheath assembly are placedproximal to an exterior of a bladder of the patient and proximal to abladder neck of the bladder.
 17. The method of claim 10, wherein theimplantable device comprises an adjustable device comprising anadjustable balloon connected to a self sealing port via a conduit. 18.The method of claim 10, wherein the trocar is formed of material that issteam sterilizable.
 19. The method of claim 10, wherein the needle thatis employed with the trocar is a hubless needle or a needle with aremovable hub.